510(k) K990293
- Device
- ALADDIN II MONITORING OXYGEN/AIR MONITOR
- Applicant
- HAMILTON MEDICAL, INC.
- 510(k) number
- K990293
- Product code
- BZR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-16
- Date received
- 1999-01-29
- Regulation
- 868.5330
- Classification name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMOTHY Y COWART
- Address
- 3371 Lenora Church Rd. Snellville GA US 30039 30039
FDA Registration Numbers#
- 3001311285
- 2020676
- 3010396502
- 9710644
- 3029906224
- 3010164069
- 8020893
- 3018783526
- 2085602
- 3005587132
- 3000126629
- 1928237
- 3009490946
- 3016618143
- 1722070
- 3005652389
- 9610861
- 3013156250
- 8030673
- 2523148
- 3008363989
- 3009736547
- 1314417
- 1218704
- 3011780089
- 2028807
- 3013421741
- 3023272766
- 3005347827
- 2518157
- 3004122598
- 3005998497
- 2024500
- 3001421318
- 1219324
- 9611451
- 3030149975
- 3005012805
- 3014766741
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BZR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243917 | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 |
| K241465 | Midas Flowmeter; eAVS | Parker Hannifin Corporation | 2024-09-19 |
| K231895 | Maxtec MaxBlend2+p | Maxtec, LLC | 2023-12-04 |
| K230987 | FlowStar Analog Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023-09-14 |
| K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | 2023-07-28 |
| K221494 | Quality Mix Blender, Oxymixer | Dehas Medical Systems GmbH | 2023-01-23 |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | Parker Hannifin | 2021-04-22 |
| K173205 | Equinox Advantage | O-Two Medical Technologies, Inc. | 2018-08-29 |
| K161718 | MaxBlend 2, MaxBlend Lite | Maxtec, LLC | 2016-10-27 |
| K142291 | GMX Series Medical Air/Oxygen Blender | Gentec (Shanghai) Corporation | 2015-05-19 |
| K113687 | EQUINOX RELIEVE | O-Two Medical Technologies, Inc. | 2012-04-30 |
| K113232 | MAXMIXING BLOCK | Maxtec, Inc. | 2012-03-01 |
| K101286 | SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 | Linde Healthcare AB | 2011-10-20 |
| K103317 | RESUSCITATION UNIT 105 | Atom Medical Corporation | 2011-04-20 |
| K092484 | HELIOX LOW FLOW SENTRY BLENDER | Cardinal Health 207, Inc. | 2010-04-02 |
Legacy Summary#
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FDA Review#
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